Other Applicable Legislation

Recommendation 2013/473/EU
⇨ On the audits and assessments performed by notified bodies in the field of medical devices


COM(2012) 540
⇨ Communication on safe, effective and innovative medical devices and in vitro diagnostic medical devices for the benefit of patients, consumers and healthcare professionals
.


PROPOSALS FOR A REGULATION


Proposal for a Regulation for MDD
⇨ Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009


Proposal for a Regulation for IVD
⇨ Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices


EXTERNAL WEBSITES


Interpretative Documents
⇨ Interpretative Documents


Medical Devices Harmonized Standards
⇨ Medical Devices Harmonized Standards


In Vitro Diagnosis Harmonized Standards
⇨ In Vitro Diagnosis Harmonized Standards


Active Implantable Medical Devices Harmonized Standards
⇨ Active Implantable Medical Devices Harmonized Standards


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